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Opzelura
Ruxolitinib
$2200.00
1.5% · 100 grams
BrandBranded medicine· By Incyte
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FDA boxed warningSerious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis
SERIOUS INFECTIONS
Reported infections include:
Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
Invasive fungal infections, including cryptococcosis, and pneumocystosis.
Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.
The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA.
MORTALITY
MALIGNANCIES
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
THROMBOSIS
conditions.
About Opzelura
Overview
Opzelura is a prescription cream containing ruxolitinib, a Janus kinase (JAK) inhibitor. It treats mild to moderate atopic dermatitis in adults and children aged 2 years and older who are not immunocompromised, when other prescription skin treatments do not adequately control the condition or are not advisable. It also treats nonsegmental vitiligo in adults and children aged 12 years and older. Ruxolitinib blocks the JAK1 and JAK2 enzymes involved in immune signalling, although how blocking these specific enzymes relates to its treatment effects is not currently known.
What it treats
- Mild to moderate atopic dermatitis in adults and children aged 2 years and older who are not immunocompromised, when topical prescription treatments do not adequately control the condition or are not advisable. Used for short-term treatment or longer-term treatment with breaks. - Nonsegmental vitiligo in adults and children aged 12 years and older.
Safety information
Side effects
Common side effects reported with Opzelura for atopic dermatitis include nose and throat infections, diarrhea, bronchitis, ear infections, hives, inflamed hair follicles, tonsillitis, runny nose, upper respiratory tract infections, COVID-19, reactions where the cream is applied, and fever. Blood tests may show increased eosinophils or decreased white blood cells. For nonsegmental vitiligo, common side effects include acne, itching or redness where the cream is applied, nose and throat infections, headache, urinary tract infections, and fever. Serious risks include serious bacterial, fungal and viral infections; blood clots; basal cell and squamous cell skin cancers; and low blood cell counts, including low platelets, anemia and low white blood cells. Contact your doctor promptly if you develop an infection or suspect a serious side effect. Your doctor should monitor for infections, arrange periodic skin examinations during treatment and afterward as appropriate, and check blood counts when clinically indicated.
FDA boxed warning
Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis
SERIOUS INFECTIONS
Reported infections include:
Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
Invasive fungal infections, including cryptococcosis, and pneumocystosis.
Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.
The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA.
MORTALITY
MALIGNANCIES
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
THROMBOSIS
conditions.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The FDA label lists no contraindications for Opzelura. However, serious bacterial, mycobacterial, fungal and viral infections have occurred. Regular monitoring for infection and prompt treatment are needed. Other warnings include blood clots, basal cell and squamous cell skin cancers, and low blood cell counts. Periodic skin examinations are recommended during treatment and afterward as appropriate. Complete blood count monitoring may be needed. The label also notes that oral JAK inhibitors have been associated with increased cholesterol and triglycerides, and low blood sugar in people with diabetes. Do not breastfeed during treatment.
Interactions
Drug interaction studies have not been conducted with Opzelura. Avoid using it with medicines that strongly block the enzyme CYP3A4, as these may increase ruxolitinib levels in the body and the risk of side effects. Medicines that increase CYP3A4 activity may lower ruxolitinib levels. Ask your doctor to check your other medicines for these interactions.
Using Opzelura
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C with the cap closed, away from direct light and heat. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label OPZELURA (RUXOLITINIB) CREAM [INCYTE CORPORATION] (DailyMed, retrieved 19 September 2026).
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